Symposium 2022 | Collections | Regulatory Rapporteur

December 2022 | Vol. 19 | No.11

TOPRA Annual Lecture:
Access to medicines beyond Europe:
The potential of reliance
By Francesca Buttigieg
HM1: A decade of innovative clinical trials: What have we learned and where are we going?
By Frederic Pailloux
HM2: Are expedited programmes delivering on the promise to accelerate drug development and patient access?
By Segolene Saintpierre
HM3: Lessons learned and strategic priorities
By Sobhey Nassar
HM4: Assessing the value of innovative therapies: trends, challenges and learnings
By Claire Levee
HM5: Digital health opportunities and advancements in healthcare
By Celia Cruz
HM6: Innovation in regulatory science – The path from data to evidence and the promise to streamline the regulatory lifecycle
By Segolene Saintpierre
HM7: Are patients the missing piece in the global drug development puzzle?
By Sarah Heraghty
HM8: The present and future of developing and commercialising cell and gene therapies in a global world
By Nathalie Bourrit
HM9: Strategy under uncertainty — Improving the odds of regulatory success
By Francesca Buttigieg
VM1: Availability and Innovation - under a new VMP legislation
By Rhona Banks
VM2: Novel therapies in animal health – Balancing guidance versus gaining flexibility
By Mel Munro
VM3: Antimicrobials; the new rules, their impact and consequences
By Beate Lohr
VM4: Regulatory update and perspectives: Variations, packaging and labelling, pharmacovigilance
By Kornelia Grein
VM5: CVMP Guidelines Update:
Data protection (Article 40.5),
prescription status (Article.34) and benefit-risk
By Pascale Canning
MD2: How to approach Artificial Intelligence
and Cybersecurity now and in the future
By Mehryar Behizad
MD3: Clinical investigation from
a virtual setting perspective
By Mehryar Behizad
MD4: Challenges and opportunities for
small companies and start-ups
By Michael Kipping
MD5: How to maintain your medical device
on the market and fulfil ongoing obligations
in the post-launch phase
By Mehryar Behizad
IVD1: Current state –
and update on IVDR implementation
By Esteban Herrero-Martinez
IVD2: Clinical Performance Evaluation Challenges
By Esteban Herrero-Martinez
IVD3: IVDR for small companies and start-ups
By Celia Cruz